EXHIBIT 10.61
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PATENT AND KNOW-HOW LICENSE AGREEMENT
This Agreement is entered into between
Amdex A/S
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Denmark
(in the following referred to as the "Licensor")
and
Synbiotics Corporation
11011 Via Frontera
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(in the following referred to as the "Licensee")
Whereas:
Licensor is entitled by virtue of the Transfer of Rights Agreement by and
between Licensor and [*] to exclusive rights under the Patent and the inventions
the subject of the Patent (the "Inventions") and is entitled to license other
companies under the Patent and in connection with the Inventions; and
Licensor is in possession Of valuable know-how and technical information
relating to the Inventions including but not limited to manufacture of water-
soluble polymeric conjugates of the type described in the Patent ("Know How");
and
Licensor has informed Licensee that the various applications and patents
identified in Appendix 8 hereto constitute all of the patent protection relating
to the Inventions and that the current status of the applications and patents is
as stated in Appendix 8;
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[*] Certain confidential portions of this exhibit have been omitted by means of
blacking out the text (the "▇▇▇▇"). This exhibit has been filed separately
with the Secretary of the Commission without the ▇▇▇▇ pursuant to the
Company's Application Requesting Confidential Treatment under Rule 24b-2
under the Securities Exchange Act of 1934, as amended.
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Licensee has had the opportunity to review the patent application submitted and
has reviewed the status thereof with Licensor;
Licensor has agreed to supply to Licensee the Licensed Products and has agreed
that Licensee may use the Licensed Products and may use and sell Licensee
Products. Licensor shall use the Know How which it has developed and which it
will in future develop in the development and manufacture of the Licensed
Products.
Now, therefore, in consideration of the premises and the mutual promises and
covenants set forth below, Licensor and Licensee mutually agree as follows:
Clause 1
Definitions
"Affiliate" shall mean (a) any company owned or controlled to the extent of at
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least fifty percent (50%) of its issued and voting capital by a party to this
Agreement and any other company so owned or controlled (directly or indirectly)
by any such company or the owner of any such company, or (b) any partnership,
joint venture or other entity directly or indirectly controlled by, controlling,
or under common control of, to the extent of fifty percent (50%) or more of
voting power (or otherwise having power to control its general activities), a
party to this Agreement, but in each case only for so long as such ownership or
control shall continue.
"Agreement" shall mean this Patent and Know-How License Agreement, as amended
from time to time.
"Development Project" shall mean the development/research work to be performed
by Licensor under this Agreement for the creation of the Licensed Product.
"Development/Research Terms" shall mean those terms governing the development of
the Licensed Product(s) as set forth in Appendix 5 attached hereto.
"Escrow Agent" shall have the meaning set forth in Appendix 1 Section (B).
"License" shall mean the license granted under this Agreement for the use of the
Licensed Products, as defined below.
"License Fee" shall have the meaning set forth in Clause 16(i).
"Licensed Product" shall mean any and all [*] developed and generated by
Licensor (or Licensee solely under the terms of this Agreement and utilizing
Licensor Know How and the Manufacturing Details) for use in products for (i) the
diagnosis and detection of infectious and other diseases in animals, (ii) the
diagnosis and monitoring of allergy in animals and (iii) the measurement of
hormones and drugs in animals, and any and all improvements or modifications
made thereto.
"Licensee Product" shall mean those assay kits and/or other diagnostic products
manufactured and sold by Licensee which incorporate the Licensed Product.
"Manufacturing Details" shall mean all technical information for the routine
manufacture of the Licensed Products as set forth generally in Appendix 1
Section A and as to be deposited by Licensor with the Escrow Agent.
"Materials" shall mean all advertising and promotional materials referencing the
Licensee Products.
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"Minimum Payment" shall have the meaning set forth in Clause 17.
"Patent" shall mean applications for patents relating to the Inventions and
patents granted pursuant to those applications as set forth in Appendix 8 to
this Agreement and all applications and granted patents relating to improvements
relating to the Inventions and modifications thereof. (Each shall be "a Patent",
collectively "the Patents").
"Raw Material" shall mean the antibodies to be supplied by Licensee, or
suppliers controlled by Licensee, to Licensor for use in the development and
production of the Licensed Products.
"Territory" shall mean the geographic scope of the License as set forth in
Clause 8.
"Transfer of Rights Agreement" shall mean the agreement between [*].
Clause 2
Scope of the License
The License hereby granted to Licensee is for the supply of and use and sale of
the Licensed Product incorporated into assay kits and other diagnostic products
for (i) the diagnosis and detection of any and all infectious and other diseases
in animals, (ii) the diagnosis and monitoring of allergy in animals and (iii)
the measurement of hormones and drugs in animals (the "Licensee Products").
Excluded from the License is the use and sale of assay kits and other diagnostic
products incorporating the Licensed Products in the research and development of
medicines for human therapeutic use.
Also excluded from the License shall be conjugates developed for hormone
determination in animals for research and development purposes and drugs of
abuse in animals.
In the event of a default by Licensor under the provisions of Clause 25 and
Appendix 1 hereof, Licensee is hereby granted an exclusive license to produce,
use and sell the Licensed Products directly utilizing the Know-How and
Manufacturing Details held in escrow by the Escrow Agent on the same terms and
conditions as set forth herein (the "Default License").
Clause 3
Technical Field of Application
The License hereby granted is for Licensee's use of the Licensed Product only as
labelled with the two classes of labels, enzymes and dyes. The class of enzymes
includes, but is not limited to, [*] and [*] and the class of dyes includes, but
is not limited to, [*] and [*]. Excluded from the class of dyes are the [*]
dyes. The Licensed Product may be used as a primary or as a secondary reagent
incorporating [*]. The Licensed Product may be used in all assay formats for
example the standard microwell format (i.e. 96 well microtitre plates),
dipstics, lateral flow devices or flow-through membrane devices.
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Clause 4
Exclusivity of License
The License is exclusive for the scope defined in Clause 2 and the technical
field of application defined in Clause 3 above. The exclusive grant hereunder
shall remain in effect for the term of this License and any Default License,
except as set forth in Clause 27(i) hereof.
Clause 5
Authorization
Licensor has all necessary consents, permits or authorizations required under
current law from any relevant governmental body or from any other person, firm
or corporation under any Agreement to which Licensor may be a party to grant
this License to Licensee and to perform the obligations set forth herein.
Licensor agrees to keep in force all agreements which would affect the validity
of this License including, but not limited to, the Transfer of Rights Agreement.
Clause 6
Non Assignment and Non Disposal
Neither party shall assign, sub-contract or otherwise dispose of the whole or
any part of its rights and obligations under this Agreement without the prior
written consent of the other except that either party may assign the benefit of
this Agreement to any of its Affiliates. No such assignment shall relieve the
assigning party of its obligations hereunder at the time of its assignment.
This Agreement shall be assigned to any party that purchases all or
substantially all of the assets or the conjugate business of Licensor. Licensor
shall provide any purchaser of substantially all of its assets or its conjugate
business with a copy of this Agreement and shall obtain from such purchaser
written confirmation of their understanding and acceptance of the terms hereof
and the obligations contained herein.
Clause 7
Grant of Sub-Licenses
Licensee shall not grant a sub-license to any party, except an Affiliate of
Licensee, without consent from Licensor.
Clause 8
Territory of License
The License is granted on a worldwide basis.
Clause 9
Trademarks
Each and every Licensee Product shall be advertised and sold by Licensee under
both Licensee's and Licensor's trademark. Licensor's trademark shall be
displayed according to the guidelines set out in Appendix 4 attached hereto.
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Licensee's trademarks shall at all times remain the exclusive property of
Licensee and shall not be used by Licensor without the express written
permission of Licensee.
To the best of Licensor's knowledge, Licensee may lawfully import, distribute,
advertise, market, promote, offer for sale, and sell the Licensee Products under
Licensor's registered trademark in the Territory. Licensor shall take charge of
any negotiation or litigation arising out of any claim against Licensee for
infringement. The costs involved in undertaking any such negotiation and/or
litigation shall be borne by Licensor. Any damages or penalties assessed
against Licensee shall be borne by Licensor. In addition, if Licensor's
trademark is determined to infringe a third party trademark, Licensee shall be
compensated by Licensor for all costs related to the removal of the infringing
trademark from any Licensee Products in production and/or in Licensee's
inventory and any promotional or marketing materials incorporating the
infringing trademark. Licensee shall use commercially reasonable efforts to
mitigate any damages arising from the events set forth in this provision.
In the event that either party learns of any perceived infringement of the
registered trademark by a third party, the party learning of the alleged
infringement will promptly inform the other party hereto and Licensor agrees to
advise the third party of the registered trademark.
If Licensor notifies Licensee at any time of its decision not to bring any
enforcement action against any alleged infringer then Licensee will have the
right, but not the obligation, to prosecute any infringement of the trademark at
its own expense and in its own name or, if required by law, in the name of
Licensor.
In the event that this Agreement is terminated, notwithstanding the reason
therefore, Licensee shall automatically and immediately lose the right to use
Licensor's trademark. Notwithstanding the foregoing, Licensee shall be
permitted to sell any Licensee Products in its existing inventory or in
production as of the date of termination without being in breach of this Clause
9 in particular or this Agreement in general.
Licensee shall not register nor have registered Licensor's trademark set forth
in Appendix 4.
Clause 10
Technical Information
Licensor shall supply Licensee with all relevant technical information required
for the purposes only of this Agreement.
No information, however, shall be supplied by Licensor enabling Licensee to
manufacture the Licensed Products, except as required in Clause 16, cfr.
Appendix 1 and Clause 25.
Clause 11
Responsibility for Claims by Third Parties
Licensor undertakes that the use and/or sale of the Licensed Products by
Licensee does not and will not infringe any patent, registered design, trade
▇▇▇▇ or other intellectual property right of any third party and agrees to
indemnify Licensee in respect of any claims, costs (including legal costs),
losses, expenses or damages it may incur as a direct result of the breach of
this undertaking. This does not extend to loss of profit. Licensor agrees to
use its best efforts to remedy any infringement or violation and to mitigate any
damages in connection therewith.
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In the event of an infringement occurring Licensor will, at Licensor's cost, use
commercially diligent efforts either to procure the right for Licensee to
continue to sell the infringing products, or to replace the infringing products
with suitable non-infringing products.
In the event of Licensor being unable to procure the right for Licensee to
continue to sell the infringing products or to replace the infringing products
with suitable non-infringing products within a reasonable time, Licensee will be
able to terminate this Agreement forthwith by written notice to the Licensor.
Licensor shall compensate Licensee for any Licensee Products in production or
inventory which cannot be sold by Licensee or its customers as a result of
Licensor's infringement and shall reimburse Licensee for the costs of
reproducing any and all promotional, marketing or other commercial materials
referencing the infringing products. Licensor's liability hereunder shall be
limited to the lesser of (i) actual costs. damages or expenses or (ii) [*] US
Dollars (US$[*]). Licensee shall use commercially reasonable efforts to mitigate
any damages arising from the events set forth in this provision.
Clause 12
Novelty
Licensor does not warrant that the Licensed Product is novel but undertakes that
it is not aware of any prior art or prior use which might result in the Licensed
Product and Inventions being held to be not novel and not inventive. In the
event that the Patent is rejected or held to be invalid by reason of prior
publication or prior use, Licensee shall as of that point cease paying to
Licensor royalties in respect of the Licensed Product (or that portion of the
royalties relating to the jurisdiction where the Patent has been rejected or
held to be invalid). Licensor shall, however, continue to provide Licensee with
the Licensed Product and Licensee shall pay Licensor in respect of the provision
of such product in accordance with Clauses 16 and 17 hereof.
If the Patent is void and if a reputable third party supplier is able to provide
Licensee with products that are equally effective as the Licensed Products at a
cost that is at least [*] per cent ([*]%) less than the cost of the Licensed
Products under this Agreement, including all applicable royalty or product
payments then Licensee shall have the right to terminate this Agreement, after
Licensor has had the opportunity to match such price and has refused, on [*]
days written notice.
Clause 13
Industrial Realization and Commercial Exploitation
Licensor does not warrant that the Licensed Product is capable of industrial
realization nor shall Licensor be responsible for the consequences of any
failure so to realize it. In addition, Licensor does not warrant that the
Licensed Product is capable of commercial exploitation, the risks of such
exploitation being assumed solely by Licensee.
Clause 14
Manufacture and Supply of Licensed Products by Licensor
Licensee acknowledges that, except as specifically provided for in this
Agreement, it shall not manufacture the Licensed Products directly and shall not
have access to Licensor's Know-How. Licensor, therefore, shall be responsible
for the manufacture and supply to Licensee of the Licensed Products for
incorporation into the Licensee Products. Licensor acknowledges that it is the
only source of the Licensed Products and, therefore, must use its best efforts
at all times to meet the requirements of Licensee, as set forth in accordance
with Appendix 3 attached hereto, for the Licensed Products.
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(i) Licensor Warranties
Licensor warrants as follows:
that all Licensed Products manufactured and supplied under this Agreement
shall be of good marketable quality and shall accord with the
technical specifications set forth in Appendix 2 or such other
specification as has been agreed between the parties in writing in
substitution thereof;
that prior to delivery all tests and quality control procedures set out in
Appendix 2 or otherwise agreed will have been carried out in relation
to each manufacturing lot of the Licensed Products with satisfactory
results which will be made available to Licensee on delivery of the
Licensed Products. A certificate of conformity will be supplied by
Licensor with each lot delivered to Licensee.
(ii) Quality Control
Without prejudice to Licensee's rights hereunder Licensor will immediately
notify Licensee's Quality -Controller by rapid means of communication (eg.
facsimile, telephone) in the event of any circumstance coming to their
attention which would be reasonably expected to lead to a claim being made
against Licensee, its subsidiaries, affiliates, distributors, agents and
their respective employees relating to the Licensed Products including but
not limited to any Licensed Products' failure or difficulties disclosed by
the quality control tests carried out on the Licensed Products by Licensor
or any continued stability testing or of non-Licensee customer complaints
to Licensor relating to the materials comprised in its Licensed Products
or any other aspect thereof, the details of such notification to be
confirmed in writing.
Licensor will disclose to Licensee particulars of the results of
Licensor's quality control tests carried out on the Licensed Products at
Licensee's request and will, at Licensee's request permit a duly
authorized representative of Licensee to visit and review the quality
control and quality assurance procedures of the Licensor of the Licensed
Products on thirty (30) days notice.
Alterations in quality control procedures and technical specifications
with respect to Licensed Products for Licensee may be introduced from time
to time by prior written agreement between Licensor and Licensee.
(iii) Claims
On receipt of any bona fide claim substantiated by data, Licensor will
within thirty (30) days provide Licensee or its subsidiary, affiliate,
distributor, agent or customer with replacement Licensed Products, or
parts thereof, to the extent necessary to meet Licensor's warranties
contained in this clause or to make good any shortages or non completed
deliveries.
(iv) Storage/Use
Licensee undertakes to store the Licensed Products and to make written or
verbal claims about the Licensed Products in accordance with the
specifications to be agreed between the parties. Licensor will have no
obligation to make replacements or otherwise (or have any liability
hereunder) as a result of fault or negligence or improper or unauthorized
use of the Licensed Products by Licensee or the ultimate user of the
Licensed Products.
Licensee acknowledges that Licensed Products supplied by Licensor are
based on front line research and technology and have yet to be fully
characterized in terms of their toxicity, allergenicity and the like. In
the light thereof all Licensed Products are sold and delivered under the
mutual understanding between the Licensor and the Licensee that the latter
or his staff, who shall deal with or use the Licensed Products at
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any time shall be in possession of adequate education and all other
relevant skills necessary for the proper and rightful handling and use
of such potentially hazardous Licensed Products.
(v) Quantity; Forecasts
Appendix 3 attached hereto sets forth in detail the requirements for
forecasting and submitting orders.
(vi) Delivery
Deliveries from the Licensor shall be FCA (Incotenns) Copenhagen.
Licensor shall upon Licensee's request arrange for shipping of the
Licensed Product to a location specified by Licensee. Shipping and
insurance charges and all other costs related to transportation of the
Licensed Product from Licensor's premises shall be borne by Licensee.
Licensee shall satisfy itself as to the requirements of law or other
regulations governing the import and entry of the Licensed Products into
its own country and to obtain all necessary licenses, consent or
approval required to import the goods, whereas Licensor shall arrange
for any approval from the Danish authorities for export of the Licensed
Products.
(vii) Licensed Product Price
The parties agree to negotiate in good faith the price per liter of
Licensed Product on the basis that current knowledge is insufficient to
arrive at a justifiable price ("Licensed Product Price"). In the event
that the parties are unable to reach an agreement as to the Licensed
Product Price within three (3) months of the date of this agreement
Licensor agrees to submit manufacturing details to an independent
contract producer, agreed to by Licensee, and Licensee will submit
volume requirements and QC specifications for the Licensee Products. The
parties hereby agree to be bound by the price per liter established by
the contract producer. The Raw Material shall at all times be supplied
by Licensee to Licensor free of charge. If production costs for Licensor
change significantly during the course of this Agreement Licensee and
Licensor agree to negotiate an adjustment in the Licensed Product Price,
to be held constant thereafter for a minimum of 12 months.
Proprietary rights and title to the Licensed Product shall remain with
Licensor until the Licensed Product Price has been received by Licensor,
whether or not Licensee has taken delivery of the Licensed Product.
(viii) Indemnification
Licensor shall indemnify Licensee against any and all liability,
damages, costs and expenses, including without limitation reasonable
attorneys' fees, made against or sustained by Licensee or any Affiliate
arising from the use of the Licensed Product and any reasonable out-of-
pocket costs to Licensee and/or its Affiliate for the recall of any
Licensee Products as a direct result of a manufacturing defect in the
Licensed Product. Any liability arising under this provision shall be
limited to the lesser of (i) actual damages, costs and expenses or (ii)
[*] US Dollars (US$[*]).
(ix) Authorization
Licensor has all necessary consents, permits or authorizations required
under current law from any governmental body where the Licensed Product
is manufactured and/or supplied from or from any other person, firm or
corporation under any Agreement to which Licensor may be a party to
manufacture and supply the Licensed Products to Licensee.
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Clause 15
Modifications and Improvements to Licensed Products
Licensor shall disclose and make available to Licensee, free of charge, any and
all material modifications and improvements to the Licensed Products devised by
Licensor during the course of this Agreement.
Clause 16
Payment of License
(i) One-time License Fee
In consideration for the License granted under this Agreement and the
entering into by the parties of the Development/Research Terms attached
hereto as Appendix 5, Licensee shall pay to Licensor a one-time non-
refundable license fee in the amount of [*] US Dollars (US $[*]) (the
"License Fee"). The License Fee shall be paid in accordance with Appendix
9 attached hereto.
(ii) Royalty Payments
Licensee shall pay to Licensor a royalty on its sales of Licensee
Products in countries where Patent protection is subsisting based upon
the net sale price. The royalty shall be calculated as follows:
a) Existing products manufactured and sold by Licensee (including updated
or modified versions of such existing products) into which currently
used reagents are substituted with Licensed Products (an exhaustive
list of existing products is attached hereto as Appendix 6):
i) a [*] per cent royalty on any sale of Licensee Products by
Licensee; and
ii) an additional [*] per cent royalty on those sales of a particular
Licensee Product that exceed the 1996 sales of that same product.
For products introduced during 1996 the royalty shall be based on
annualized sales, not actual sales
b) Products not previously manufactured and sold by Licensee, i. e.
products not mentioned or specified in Appendix 6 and into which
Licensed Products are incorporated:
i) a [*] per cent royalty on any sale.
(iii) Product Fees
a) If a Patent is not granted in any one of the countries listed on
Appendix 7 attached hereto, with claims covering [*] as used in the
Licensed Product then the royalty payments described in (ii)(a)
through (ii)(c) above shall not apply as to sales made in that country
and Licensee shall pay to Licensor a product fee in the amount of [*]
per cent on sales of Licensee Products in that country for the
remaining period of this Agreement.
b) When a Patent and the protection connected thereto ceases in a
particular country, the royalty payments described in (ii)(a) through
(ii)(c) shall no longer be payable as from the date of cessation in
respect of sales in that country. Licensee shall be obligated to pay
to Licensor a product fee in the amount of [*] per cent of the sales
of Licensee Products in that country for the remaining period of this
Agreement.
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c) In those countries where Licensee is selling products but where
Licensor has no subsisting Patent protection the provisions of
sections (ii)(a) through (ii)(c) shall not apply and Licensee shall
pay to Licensor a product fee in the amount of [*] per cent of the
sales of Licensee Products in those countries for the term of this
Agreement.
(iv) In the event that Licensee is producing the Licensed Products itself for
any of the reasons set forth in Clause 25 and/or Appendix 1, Licensee
shall continue to pay a royalty or payment, as appropriate, on sales of
Licensee Products in accordance with Sections (ii) and (iii) above.
(v) Each party shall at all times be responsible for its own charges, taxes
and duties relating to the sale or purchase, as appropriate, of the
Licensed Product(s).
Clause 17
Minimum Payments
Licensee shall pay to Licensor a minimum payment of [*] US Dollars (US$[*]) per
year (the "Minimum Payment"). The Minimum Payment shall commence on January 1,
1997, however, payments shall not begin until the initial commercial sale of a
Licensee Product. If there are no sales of Licensee Products during 1997,
Licensor shall receive a one-time payment of [*] US Dollars (US$[*]) within 10
working days of December 31, 1997 (the "Sales Payment"). In the event of the
Patent not being granted, Patent protection ceasing or no Patent protection is
subsisting in a country listed on Appendix 7, the Minimum Payment shall be
reduced by the percentage applicable to that country, as set forth on Appendix
7. For example, if the Patent is not granted in the United States, the Minimum
Payment shall be reduced, pro rata, by [*]% from the date that the relevant
examination authority or court, as the case may be, issues its
rejection/decision of invalidity. In the event that an appeal of that decision
is successful and the patent is reinstated Licensee shall as from the date of
the Appeal decision pay the full minimum payment. The Minimum Payment shall
continue for the Term of this Agreement in accordance with the provisions of
Clause 27(i) hereof.
Clause 18
Time when Right to Payment Accrues
The right to payment accrues on the date of the Licensee's receipt of payment
from its customer. The provision of the payment shall be made in accordance
with Clause 20 below.
Clause 19
Reports and Inspection of Accounts
Licensee shall provide to Licensor on a semi-annual basis a report of the exact
number of Licensee Products sold and any other information relevant for
determining the payment due.
Licensor shall have the right by means of an independent accountant appointed by
Licensor and approved by Licensee (such approval not to be unreasonably
withheld) to examine semiannually whether the reports provided are consistent
with the general accounts of Licensee. The costs of such inspection and
examination shall be borne by Licensor. Licensor shall ensure that the
independent accountant shall limit its review to a reconciliation of the reports
and accounts and that he/she shall keep confidential any information regarding
Licensee's business or customers from Licensor and/or any third party.
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Clause 20
Settlement of Accounts and Payment
Accounts shall be rendered and settled quarterly in arrears. Until the parties
agree otherwise, the quarterly payment shall be the Minimum Payment stipulated
in Clause 17, i.e. a Minimum Payment paid quarterly of [*] US dollars (US$[*]),
or such greater amount as may be determined in accordance with Clause 17. For
example, if the initial commercial sale of a Licensee Product is made in March
1997, Licensor shall receive three (3) quarterly payments of [*] dollars and [*]
cents ($[*]) each. After the expiry of each calendar year Licensee shall,
within thirty (30) days, send to Licensor a complete and accurate account of the
sales of Licensee Products in the previous calendar year showing any sum in
excess of the Minimum Payment due to the Licensor thereunder.
Settlement of the excess payment due shall be made on or before the 15th
February, or the next business day if the 15th falls on a weekend or public
holiday, and shall be made in US dollars. The Licensor shall be entitled to
interest on any sum overdue, the interest being calculated at [*] per cent
([*]%) per month.
Clause 21
Manufacture or Sale of Competing Products
The Licensee shall not manufacture or sell products which would be in direct
competition with the Licensed Products or any improvement made available to
Licensee by Licensor during the period of this Agreement. Nothing in this
Clause shall prevent Licensee from manufacturing or selling products which
incorporate products which compete with the Licensed Products.
Clause 22
Maintenance in Force of the Patent
Once a Patent has been granted in a particular country, Licensor shall keep in
force that Patent. Licensor shall keep Licensee informed of the status of the
Patent applications and shall give Licensee notice of any grant or rejection and
any subsequent appeal, of a particular application, and any subsequent appeal,
within ten (10) business days of their receipt of notification from the relevant
patent authority.
Clause 23
Protection of the Patent
In those countries where a Patent has been granted and Licensee has been
informed that the Patent is in effect, Licensee shall notify Licensor of any
infringement of the Patent that Licensee becomes aware of.
Licensor may take proceedings against the infringer and Licensee shall provide
all necessary assistance at Licensor's expense. If Licensor determines not to
proceed against the infringer and, if the applicable taw permits, Licensee may
proceed with the prior written consent of Licensor, such consent not to be
unreasonably withheld. In the event of the foregoing, Licensor shall provide
all necessary assistance to Licensee, at Licensee's expense.
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Clause 24
Exploitation of the License
Licensee shall use its best efforts to exploit the License in a commercially
reasonable manner. Licensee shall use the Licensed Products wherever
commercially practicable in all products listed in Appendix 6.
Clause 25
Events of Default
In addition to any other remedies set forth in this Agreement or provided for at
law, either party shall have the right to terminate this Agreement if the other
party shall have materially defaulted in the performance of any material
agreement, condition or covenant contained in this Agreement which default has
not been remedied after notice and the opportunity to cure.
In addition to those Release Events set forth in Appendix I Section B, a
material default shall be deemed to have occurred in a case where any obligation
of payment is not settled within thirty (30) days of notice thereof.
In the event of any default hereunder, the non-defaulting party shall give the
defaulting party written notice of such default and the opportunity to cure such
default within thirty (30) days, unless otherwise limited herein.
Within thirty (30) days of the parties reaching an agreement as to the final
specifications of the Licensed Product, Licensor shall deposit the information
necessary to enable Licensee to start its own production of the Licensed Product
to be held in escrow by the Escrow Agent. Such information shall be released to
Licensee in the event of the conditions outlined in Appendix I having taken
place.
The Terms and Conditions for the Escrow Agent's obligations to deliver and
release information to Licensee are listed in Appendix 1. In the event of
Licensee taking over production of the Licensed Products, Licensee shall pay a
royalty to Licensor in accordance with the provisions contained in Clause 16
(iv) above.
Clause 26
Provisions to be Observed in Case of Licensee's Own Production
In the event of Licensee taking over production of the Licensed Products, no
authorization of Licensor shall be required for making modifications or
improvements to the Licensed Products, provided that any modifications or
improvements made shall be communicated to Licensor.
Licensor shall be entitled to make use, free of charge, of any modifications and
improvements suggested by the Licensee.
Clause 27
Term of the Agreement and Termination
(i) Term
The Agreement shall take effect on the date set forth on the signature page
hereof. The Agreement shall run for a period of ten (10) years. On the
fifth anniversary of this Agreement the parties shall meet to
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review the terms of the Agreement. Minimum Payments for the first five year
period shall be as set forth in Clause 17 hereof.
If at the end of the first five year period the royalty/payment stream set
forth in Clause 16 hereof does not exceed the Minimum Payment set forth in
clause 17 hereof then Licensor shall have the right to make this Agreement
non-exclusive. In the event of the foregoing, for the second five year
period there will be no Minimum Payment as set forth in Clause 17 and
percentage royalties, where applicable, shall be paid at a rate of [*]% of
sales of Licensee Product.
During the term of this Agreement the parties shall meet every three (3)
years to review those areas in the scope of this Agreement that Licensee is
not actively pursuing. Unless Licensee commits to a development program in
those areas, agreed to by Licensor Licensor shall be free to license to
third parties the Inventions and Know-How in those areas only from that
time. In the event of the foregoing, Licensee shall have non exclusive
rights to the non-exclusive areas of activity.
(ii) Termination
The Agreement may be terminated prior to the end of the Term only in the
event of any of the following':
(a) at any time, upon mutual written agreement of the parties; or
(b) by a non-defaulting party in accordance with the provisions of Clause
25; or
(c) by Licensee in the event that the Development Project is not completed
in accordance with Appendix 5 attached hereto.
Clause 28
Mutual Confidentiality
Neither party shall, during the period of this Agreement or after termination,
either by expiry or by breach, for a period of ten (10) years, communicate to
third parties, either parties' trade or manufacturing secrets or any other
confidential information disclosed by either party pursuant to this Agreement.
After termination of this Agreement, both parties shall cease using any
confidential information received in connection with this Agreement and shall
return to the other party immediately all documents relating to the manufacture
of either the Licensed Products or the Licensee Products, except for one copy
retained for legal/archival purposes.
Clause 29
Applicable Law
This Agreement shall be governed by the laws of the Kingdom of Denmark.
-13-
Clause 30
Competent Jurisdiction/Arbitration
Should any dispute arise between the Parties concerning the execution and/or
interpretation of this Agreement, the Parties will endeavor to solve the dispute
in an amicable way.
If no amicable settlement can be reached between the parties concerning a
dispute, such dispute shall be settled finally by binding arbitration.
Arbitration shall be held in The Hague, the Netherlands and shall be conducted
in English in accordance with the Rules of Conciliation and Arbitration of the
International Chamber of Commerce, as in effect on the date of the commencement
of the arbitration.
Clause 31
Entire Agreement
This Agreement, including the Appendices hereto which are incorporated into this
Agreement, contains the entire agreement of the parties regarding the subject
matter hereof and supersedes all prior agreements, understandings and
negotiations regarding the same. This Agreement may not be changed, modified,
amended or supplemented except by a written instrument signed by both parties.
Furthermore, it is the intention of the parties that this Agreement be
controlling over additional or different terms of any order, confirmation,
invoice or similar document, even if accepted in writing by both parties, and
that waivers and amendments shall be effective only if made by non-pre-printed
agreements clearly understood by both parties to be an amendment or waiver.
Clause 32
Controlling Language
The official text of this Agreement shall be the English language, and such
English text shall be controlling in all respects, notwithstanding any
translation hereof required under the laws or regulations of any other country.
The par-ties undertake to use the English language in respect of all documents
and communications contemplated hereby, except where another language must be
used under the laws and regulations of another country. In any such a case, a
certified English translation shall be supplied to the other party by the party
using such document or making such communication.
Clause 33
Severability
If any provision of this Agreement shall be held illegal or unenforceable, that
provision shall be limited or eliminated to the minimum extent necessary so that
this Agreement shall otherwise remain in full force and effect and enforceable.
Clause 34
Further Assurances
Each party hereto agrees to execute, acknowledge and deliver such further
instruments, and to do all such other acts, as may be necessary or appropriate
in order to carry out the purposes and intent of this Agreement.
-14-
Clause 35
Notice and Reports
All notices, consents or approvals required by this Agreement shall be in
writing sent by certified or registered air mail, postage prepaid or by
facsimile or cable (confirmed by such certified or registered mail) to the
parties at the addresses set forth on page 1 of this Agreement or such other
addresses as may be designated in writing by the respective parties. Notices
shall be deemed effective on the date of mailing.
Clause 36
Relationships of the Parties
Both parties are independent contractors under this Agreement. Nothing
contained in this Agreement is intended nor is to be construed so as to
constitute Licensor and Licensee as partners, agents or joint venturers with
respect to this Agreement. Neither party hereto shall have any express or
implied right or authority to assume or create any obligations on behalf of or
in the name of the other party or to bind the other party to any contract,
agreement or undertaking with any third party.
Clause 37
Waiver
The waiver by either party of a breach of any provisions contained herein shall
be in writing and shall in no way be construed as a waiver of any succeeding
breach of such provision or the waiver of the provision itself.
Clause 38
Captions
Paragraph captions are inserted for convenience only and in no way are to
construed to define, limit or affect the construction or interpretation hereof.
Clause 39
Force Majeure
A party shall not be liable for nonperformance or delay in performance (other
than of obligations regarding payment of money or confidentiality) caused by any
event reasonably beyond the control of such party including, but not limited to
wars, hostilities, revolutions, riots, civil commotion, national emergency,
strikes, lockouts, epidemics, fire, flood, earthquake, force of nature,
explosion, embargo, or any other Act of God, or any law, proclamation,
regulation, ordinance, or other act or order of any court, government or
governmental agency.
Clause 40
Export Control
The parties hereto agree to comply with all export laws, restrictions and
regulations of the United States as well as those of any relevant foreign agency
or authority.
-15-
Clause 41
Counterparts
This Agreement may be executed in one or more counterparts, each of which shall
be deemed to be an original, but all of which shall be one and the same
document.
[The remainder of this page has been left intentionally blank]
-16-
The parties hereto have executed this Agreement to be effective as of this 29th
day of August, 1996.
As Licensor: As Licensee:
/s/ ▇▇▇▇▇▇ ▇▇▇▇▇ /s/ ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇
------------------------- -------------------------------
By: ▇▇▇▇▇▇ ▇▇▇▇▇ By: ▇▇▇▇▇▇▇ ▇▇▇▇▇
Title: Managing Director Title: Chief Executive Officer
/s/ Gunnar Aass
-------------------------
By: Gunnar Aass
Title: Chairman
The undersigned hereby agree to be made a party to this Agreement solely as to
Clauses 1, 2, 3, 4, 29 and 30 hereof and agree to be bound by the foregoing
provisions notwithstanding any rights or obligations set forth in the Transfer
of Rights Agreement.
[*] [*]
/s/ ▇▇▇▇▇▇ ▇▇▇▇▇ /s/ Gunnar Aass
------------------------- -------------------------------
By: By:
Title: Title:
-17-
Appendices:
-----------
Appendix 1: Manufacture by Licensee of Licensed Product.
Appendix 2: Technical Specifications of Licensed Product.
Appendix 3: Forecasting/Scheduling/Delivery of Licensed Product.
Appendix 4: Trademark Guidelines.
Appendix 5: Development/Research Terms.
Appendix 6: Existing Products.
Appendix 7: Countries
Appendix 8: The Patent
Appendix 9: License Fee
-18-
APPENDIX 1
Manufacture by Licensee of Licensed Product
A. Manufacture of Licensed Product by Licensee.
-------------------------------------------
What follows is a broad description of Production information which will be
placed in escrow when the specifications of particular Licensed Products are
established under the terms of Appendix 5. The list is not comprehensive as
the number of Licensed Products is anticipated to increase with time:
1. Specification.
2. Procedure for [*].
3. Procedure for [*].
4. Characterization of [*] through Characterization of the coupled label.
5. Characterization of [*] through coupling of standard antibody ligand to [*].
6. Characterization of [*] through Characterization of [*] and [*] conjugated
with standard antibody by [*].
7. Characterization of [*] Production through test of [*] standard [*].
8.1 Procedure for Production of [*] intended for [*] and characterization of
Conjugate in [*].
8.2 Procedure for Production of [*] intended for use in the [*] and
characterization of Conjugates in [*].
8.3 Procedure for Production of [*] intended for [*] and characterization of
Conjugate in [*].
B. Escrow Instructions
-------------------
In accordance with the provisions of Clause 25 of the Agreement certain
circumstances set forth therein and in items 1-4 below shall trigger the release
by the Escrow Agent of the Manufacturing Details as described generally in
Section A of this Appendix and as deposited with the Escrow Agent by Licensor.
By their signature to the Agreement and this present Appendix, the parties
jointly appoint the lawyer ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇ of the law firm Hjejle,
Gersted & ▇▇▇▇▇▇▇▇, to act as escrow agent ("Escrow Agent") and in that capacity
to act on behalf of both parties to keep in escrow the Manufacturing Details, as
amended from time to time.
The Escrow Agent shall within thirty (30) days of completion of the Development
Project, receive from the Licensor the Manufacturing Details and shall by way of
a signed copy of this Appendix, to be delivered to the Licensee, confirm safe
receipt thereof. The Escrow Agent's confirmation shall entail no guarantee that
the Manufacturing Details fulfil the Licensor's obligations under the Agreement.
Information on manufacture of a particular Licensed Product not mentioned in
Appendix 5 which in the future may fall under the present Agreement shall
similarly be transferred to the Escrow Agent upon final specifications of the
product.
-19-
The parties hereby agree that the Escrow Agent shall have the authority to
deliver to Licensee the Manufacturing Details without any delay and without
Licensor or his successors having any right or means to prevent such delivery,
in the event of any of the following (each a "Release Event"):
1. Any material breach of the Agreement on the part of Licensor, which has not
been cured in accordance with the provisions of the Agreement, it being
understood that acts or omissions assessed by the Escrow Agent to constitute
a material breach of the Agreement in relation to the release of the
Manufacturing Details be deemed such a breach; or
2. Licensor shall fail to deliver to Licensee the entire quantity of the
Licensed Product set forth in the orders submitted in accordance with
Appendix 3 provided, however, that the non-delivery by Licensor is not a
result of Licensee's failure to supply Raw Material and that the non-
delivery shall not have been remedied within fourteen (14) days' of written
notice from Licensee, which notice must have been sent within ten (10)
working days following the failure to deliver, and provided that the non-
delivery by Licensor shall not be due to a force majeure as defined in
Clause 40, for which the Licensor cannot reasonably be held responsible; or
3. Licensor shall not deliver the Licensed Product at any time to Licensee in
accordance with the specifications listed in Appendix 2, as amended from
time to time by the mutual written agreement of the parties. It is a
requirement that it be certified in writing that the Licensed Product does
not meet the specifications and the documentation thereon be sent to the
Escrow Agent by an independent reference laboratory, to be selected in
accordance with the provisions of Appendix 3, within 7 days of the receipt
of the noncomplying Licensed Product; or
4. Licensor shall be declared bankrupt or enter into a composition for the
benefit of its creditors.
Requests by Licensee for delivery of the Manufacturing Details shall be made in
writing to the Escrow Agent with a copy to Licensor and it is the obligation of
the Escrow Agent, provided that he has been supplied with the necessary
documentation and evidence by Licensee, to hand out to Licensee the
Manufacturing Details, following which the Escrow Agent shall be fully released
and discharged from any and all duties and obligations hereunder.
Licensor and Licensee expressly declare that the following provisions shall
apply in favor of the Escrow Agent:
1. Provided that the Escrow Agent has not acted negligently or fraudulently
when exercising his discretionary powers under the Agreement, the Escrow
Agent shall not be liable for any loss, cost, damages or expenses which may
result from anything done or omitted to be done by him;
2. The Escrow Agent shall be at liberty to place the Manufacturing Details in
any safe deposit, safe or other receptacle selected by the Escrow Agent, in
any part of the world, or with any bank or banking company believed to be of
good repute, and the Escrow Agent shall not be responsible for or be
required to insure against any loss incurred in connection with any such
deposit and Licensor and Licensee shall pay all sums required to be paid on
account of or in respect of any such deposit;
3. Whenever the Escrow Agent is under the provisions of this Agreement bound to
act he shall nevertheless not be so bound unless first indemnified to his
satisfaction against all actions, proceedings, claims and demands from third
parties, to which he may render himself liable and all costs, charges,
damages, expenses and liabilities, which he may incur by so doing;
-20-
4. Any documentation and/or evidence assessed by the Escrow Agent to be
sufficient to prove that a Release Event has occurred is deemed to be so;
5. Without prejudice to the above mentioned provisions it is agreed that the
liability of the Escrow Agent cannot exceed the fees received by the Escrow
Agent in his capacity as such under this Agreement.
The Escrow Agent acknowledges that time is of the essence in the performance of
its obligations and that a delay in production of the Licensed Product could
have a serious adverse impact on Licensee's business. The Escrow Agent,
therefore, shall ensure delivery of the Manufacturing Details to Licensee within
ten (10) working days of receipt of notice and evidence from Licensee of a
Release Event.
The Licensor and Licensee are jointly and severally liable for the payment of
all fees payable to and costs, charges, damages, expenses and liabilities which
are incurred by the Escrow Agent in performance of the duties hereunder.
Invoices for services should be sent to each party at the address listed on page
1 of the Agreement.
As Licensor: As Licensee:
/s/▇▇▇▇▇▇ ▇▇▇▇▇ /s/ ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇
------------------------- -------------------------------
By: ▇▇▇▇▇▇ ▇▇▇▇▇ By: ▇▇▇▇▇▇▇ ▇▇▇▇▇
Title: Managing Director Title: President and Chief Executive
Officer
/s/ Gunnar Aass
-------------------------
By: Gunnar Aass
Title: Chairman
Accepted as Escrow Agent:
/s/ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇
--------------------------
▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇
-▇▇-
▇▇▇▇▇▇▇▇ ▇
The Licensed Product manufactured by the Licensor is defined as any reagent
supplied to the Licensee that incorporates a specific binding agent, a [*] and
an enzyme or dye label.
The Licensed products will vary in technical specification depending upon the
exact nature of the specific binding agent and label. Antibodies supplied by
the Licensee may behave differently to those sourced by the Licensor.
As a general guideline the following provisional technical specifications have
been determined for other products manufactured by the Licensor and it is
expected that the Licensed Product supplied to the Licensee will fall within
these guidelines.
[*] conjugates
1. [*]
2. [*]
3. [*]
[*] conjugates
1. [*]
2. [*]
3. [*]
It is anticipated that more detailed specifications will be prepared at a later
date for each specific product to be supplied by the Licensor to the Licensee on
completion of the development program in the Licensor's laboratory.
-22-
APPENDIX 3
Forecasting/Scheduling/Delivery of Licensed Product
In accordance with Clause 14 of the Agreement, this Appendix shall set forth the
procedures to be followed in connection with (i) the ordering by Licensee and
delivery by Licensor of the Licensed Product to the Licensee and (ii) the
provision of Raw Material.
Planning/forecast:
At the latest by December 15 in any year, beginning on December 15, 1996,
Licensee shall submit to Licensor its forecast for required deliveries of the
Licensed Product during the following year. In addition, Licensee shall provide
to Licensor a schedule for its requirements as to when on a quarterly basis
deliveries of the Licensed Product must be made by Licensor. Licensor shall
within fourteen (14) working days from receipt of said forecast submit to
Licensee a schedule for its requirement for Raw Material corresponding to the
forecast.
Placing of Firm Order for Licensed Product:
Neither Licensee nor Licensor shall be bound by the figures and indications
given in the annual forecasts as described above. Licensee shall within (seven)
7 days of the beginning of each quarter give a precise and firm commitment of
its requirements for manufacture and delivery in the following calendar quarter
(the "Licensee Order").
Placing of Order for Raw Materials:
Licensor shall within seven (7) working days from the receipt of the Licensee
Order and on the basis of the Licensee Order place its order for Raw Material to
be provided by Licensee (the "Licensor Order"). Licensee shall deliver to
Licensor the Raw Material within fourteen (14) working days of receipt of the
Licensor Order.
Acceptance of Raw Material
Within fourteen (14) working days from the receipt of a particular shipment of
Raw Material, Licensor may reject the shipment if the Raw Material fails to meet
mutually accepted quality specifications to be agreed between the parties.
Licensor shall provide documentation to Licensee regarding the manner in which
the Raw Material fails to meet the specifications and Licensee shall, upon
agreement, provide to Licensor replacement Raw Material within seven (7) working
days.
Pre-delivery Sample:
Licensor shall within thirty (30) days following the receipt of a Licensee Order
forward to Licensee a pre-delivery sample. Such pre-delivery samples shall be
forwarded to Licensee's premises at ▇▇▇▇▇ ▇▇▇ ▇▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇, ▇▇ ▇▇▇▇▇,
▇▇▇, attn: ▇▇▇▇▇▇▇▇ ▇▇▇▇▇, or his designee.
If Licensee's evaluation of the pre-delivery sample concludes that it is not
acceptable and does not meet the technical specifications as described in
Appendix 2, Licensee shall within ten working days after having received the
pre-delivery sample give notification in writing to this effect to Licensor who.
If Licensor has not received such notification, Licensor shall regard the pre-
delivery sample as accepted by the Licensee and shall be under the obligation to
ship the Licensed Product described in the relevant order and based on the pre-
delivery sample Licensee or Licensee's appointee.
-23-
Replacement Batch:
If Licensor is notified within ten (10) working days that the sample is not
acceptable, Licensor shall, save for the situation described below, be obligated
to provide and send to Licensee a replacement batch within twenty (20) days of
receipt of Raw Material sufficient to produce a replacement batch.
Dispute:
If Licensor does not agree with Licensee's claim on batch failure, Licensor may
within said time limit of thirty (30) days ask an independent testing laboratory
to give an opinion and statement as to whether the pre-delivery sample sent to
the Licensee meets the technical specification of the Licensed Product as
defined in Appendix 2.
If Licensee does not agree with Licensor's claim of batch failure and subsequent
rejection of a particular shipment of Raw Material, the Licensor shall within
fourteen (14) working days submit samples and other evidence substantiating his
claims to an independent testing laboratory to obtain an opinion and statement
as to whether the disputed batch of Raw Material meets the mutually accepted
quality specification.
The parties agree to accept an independent testing laboratory selected by the
Clinical Laboratory Research Association of Germany which shall be approached by
the parties at the time of any dispute hereunder.
Stock held by Licensee:
Licensee intends at any time during the duration of this Agreement to order
quantities of the Licensed Product which will result in a sufficient stock to
support his requirements under this Agreement and will endeavor to hold a stock
of a minimum two batches of the Licensed Product at all times.
As Licensor: As Licensee:
/s/▇▇▇▇▇▇ ▇▇▇▇▇ /s/▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇
------------------------- -------------------------------
By: ▇▇▇▇▇▇ ▇▇▇▇▇ By: ▇▇▇▇▇▇▇ ▇▇▇▇▇
Title: Managing Director Title: Chief Executive Officer
/s/ Gunnar Aass
--------------------------
By: Gunnar Aass
Title: Chairman
-24-
APPENDIX 4
Description and Use of Licensor's Trademarks
Licensor is the proprietor of the trademark registrations; AMDEX 'word', VA
01.615 1996, registered in Denmark on March 15, 1996 (priority date January 9,
1995) and AMDEX 'figure' (an "X") VR 01.977 1995, shown on Schedule 1 attached
hereto, registered in Denmark on March 24, 1995, priority date January 9, 1995.
The attached Schedule 2 indicates the territories in the world where these
trademarks have been filed and their status in each territory.
The trademark registration generally covers all goods in the international
classes 1 and 5, although the specification of goods eventually might vary
according to the result of the prosecution of the applications.
Licensor intends, but is not obliged under the present Agreement, to extend the
protection of the ▇▇▇▇ to other countries as commercial conditions dictate
and/or by requests from the Licensee.
Licensor intends to discuss with Licensee the filing of new trade marks covering
the Licensed Product with the aim of jointly promoting the Licensee Products and
Licensor reagents in general.
Licensee must display the above trademarks in the Materials in accordance with
the following:
(i) The trademarks must generally be placed prominently on the Materials.
(ii) The trademarks must be at least twenty five per cent (25%) of the size of
the largest name or trademarks of the Licensee displayed on the
Materials.
(iii) Licensee shall supply Licensor with a copy of the Materials within sixty
(60) days of its publication and shall, where reasonably practicable,
accommodate any comments made by Licensor regarding the use of the
trademarks in future Materials produced.
Licensee may request written permission to display the trademarks in a
manner outside the guidelines set forth above. Such permission cannot
be assumed to be given until it has been received in writing by the
Licensee.
(iv) Licensee must indicate the status as a registered trademark by the use of
the international signs " or 3, as appropriate, placed close to the
trademarks. The Materials must indicate that the word and the figure are
trademarks of Licensor.
-25-
SCHEDULE 1
This schedule is a graphical image representing the trademark of Amdex. The
graphical image is a blackened circle with a white "X" in the middle.
-26-
SCHEDULE 2
Proprietor Country Trademark Classes App. No. App. Date Reg. No. Reg. Date Status Goods
------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*] [*] [*] [*] [*] [*]
============================================================================================================
-27-
APPENDIX 5
DEVELOPMENT/RESEARCH TERMS
These Development/Research terms set forth the understanding between Licensor
and Licensee regarding the Development Project. The development/research work
shall be carried out by Licensor in its laboratories in Copenhagen.
The Development Project shall run for twelve consecutive months starting on the
1st August 1996.
The work outlined below shall be the minimum acceptable by Licensee. Licensee
shall be permitted to review the progress of the Development Project on a
monthly basis. If the work as listed below is substantially completed within
the twelve month period, the Licensee shall add other products to be included in
the contract period. If Licensor has not completed the Development Project
outlined below by July 31, 1997 Licensee shall have the right to terminate the
Agreement and shall be released from all obligations set forth therein.
Licensee agrees to make any parties under Licensee's control having access to
Licensor's technical information under this Agreement bound to the
confidentiality provisions of the Agreement.
PROJECTS FOR DEVELOPMENT BY LICENSOR
1. [*]
The number one priority is the upgrading of the [*] test. This product,
although having adequate sensitivity, is perceived as having a [*]. It depends
on a [*] for signal development. The signal must be improved by the
substitution of an [*].
The need for urgency arises from the seasonality of [*] sales in the United
States. In order to meet the 1997 [*] season with an improved product, the
product must be ready for sale by early January of 1997.
The product and its current components are indicated on the attached diagram 1.
Licensee desires to replace the [*] pad, with a [*]. Licensee intends
ultimately to have the [*] for all procedural control lines in all [*]
diagnostics. Since the Licensee's logo is a [*], this would be the [*] for the
universal procedural line. Thus, the [*] chosen for the sample signal generator
must not be [*]. It is because of the constraints of time that in this first
improvement Licensee has decided not to opt for the development of the [*].
In order to accomplish the change to the diagnostic, Licensee will provide
Licensor with the following, in mutually agreeable quantities. Some of the
items are proposed (and are so indicated), since they are the property of [*]
and are not within Licensee' control. However, Licensee will make every effort
to see that they are made available to Licensor.
a) [*]
b) [*]
c) [*]
d) [*]
e) [*]
f) [*]
g) [*]
-28-
[*].
2. [*]
The second product is a combination product for the detection of [*], in [*]
serum or plasma. The product will be developed in conjunction with a party to
be named by Licensee, and will have a format and housing similar to that in the
attached diagram 2. This diagram also indicates the proposed principles for the
test. The tests are run on [*]. It is proposed that Licensee employ three
different colors. One color will be for the [*] and will be the same for both
tests. The other two colors will be separately employed for signal generation
with [*]. Since Licensee envisions other products with these attributes
Licensee would like to standardize the procedural control for all such products.
Since Licensee's logo is a [*]. we would propose that a [*] be developed for the
[*]. Choice of the other two colors should depend only on development of
adequate [*] when the device is run with [*] samples.
For the purpose of developing these reagents, Licensee will provide Licensor
with the following materials in amounts that are mutually agreeable.
a) [*]
b) [*]
c) [*]
d) [*]
e) [*]
f) [*]
g) [*]
h) [*]
i) [*]
j) [*]
It is anticipated that as soon as the agreement between Licensor and Licensee is
finalized, that Licensee will initiate the development of the diagnostic at the
party to be named by Licensee. As the product is developed, Licensee will
ensure, to the best of its ability, that there is adequate communication between
the party to be named by Licensee and Licensor. To facilitate this and the
initiation of the project, a scientist from Licensee will spend time at the
party to be named by Licensee at an early stage in the project program. In
addition, if it is necessary to facilitate and expedite the program, the same
scientist can visit Licensor, during the same time frame or at a later stage.
3. [*]
This is an existing product developed and marketed by Licensee. It is for use
in detecting [*]. It uses a [*] format, with [*] as the signal generator.
Licensee desires that Licensor improve the product by increasing the [*]. This
will permit [*].
For the purposes of improving the diagnostic, Licensee will provide Licensor
with the following materials in quantities mutually agreeable.
a) [*]
b) [*]
c) [*]
d) [*]
e) [*]
f) [*]
-29-
As Licensor: As Licensee:
/s/ ▇▇▇▇▇▇ ▇▇▇▇▇ /s/ ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇
------------------------- -------------------------------
By: ▇▇▇▇▇▇ ▇▇▇▇▇ By: ▇▇▇▇▇▇▇ ▇▇▇▇▇
Title: Managing Director Title: Chief Executive Officer
/s/ Gunnar Aass
-------------------------
By: Gunnar Aass
Title: Chairman
-30-
DIAGRAM 1
[*]
DIAGRAM 2
[*]
-31-
APPENDIX 6
EXISTING PRODUCTS
Product Name Description Species Test Method
=====================================================
[*] [*] [*] [*]
-----------------------------------------------------
-32-
APPENDIX 7
COUNTRIES
PERCENTAGE OF
COUNTRY TOTAL LICENSEE SALES
Australia [*]%
Austria [*]%
Belgium [*]%
Canada [*]%
France [*]%
Germany [*]%
Greece [*]%
Holland [*]%
[*] India [*]%
[*] Israel [*]%
Italy [*]%
Japan [*]%
Korea [*]%
[*] Malaysia [*]%
[*] New Zealand [*]%
Nordic [*]%
[*] Portugal [*]%
[*] South Africa [*]%
Spain [*]%
Switzerland [*]%
[*] Taiwan [*]%
[*] Thailand [*]%
[*] Turkey [*]%
U.K [*]%
U.S.A [*]%
* [*]
** This Appendix 7 may be amended from time to time by Licensee to accurately
reflect its market positions. Licensee shall provide any amended version of
this Appendix to Licensor and such amended version shall not be binding
until receipt has been acknowledged by Licensor.
-33-
APPENDIX 8
The Patent
-----------------------------------------------------
COUNTRY NUMBER STATUS
-----------------------------------------------------
[*] [*] [*]
-----------------------------------------------------
-34-
APPENDIX 9
License Fee
Payment Amount
------- ------
August 29, 1996 US$[*]
October 28, 1996 US$[*]
-35-
